Oral Probiotics vs Standard Antibiotic Therapy for Bacterial Vaginosis- A Randomised, Double Blind, Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- RECURRENCE OF BACTERIAL VAGINOSIS BY ASSESSING NUGENT SCORE (IF ABOVE SEVEN) OR AMSELS CRITERIA POSITIVE
研究概览
简要总结
Bacterial Vaginosis is a polymicrobial syndrome where the lactobacilli-dominated vaginal microflora is replaced by a mix of other, mainly anaerobic bacteria species. Renewed attention has recently been focused on approaches involving alternative ‘natural’ treatments that could be effective in the microbiological and clinical resolution of the condition without side effects. A meta-analysis involving 10 RCTs with a low or moderate risk of bias, suggested that the treatment with probiotics alone was more effective in the therapy of Bacterial Vaginosis for both short- and long-term; however, the probiotics used after antibiotic treatment was effective only for a short term
Thus, probiotics rather than antibiotics have promising results in reducing the recurrence rate of bacterial vaginosis
Thus, the aim of the study is ’to compare the efficacy of standard therapy vs oral probiotics in women with bacterial vaginosis’
100 women with bacterial vaginosis will be randomised into 2 equal groups and each group will be given either oral probiotics or Metronidazole(standard treatment) and assessed after 30 days to see for recurrence of bacterial vaginosis.
Hypothesis: Probiotics confer long term benefit for treatment of Bacterial Vaginosis as compared to Standard Antibiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Consenting women in age group of 18-45 years,
- •Presenting with discharge per vaginum.
排除标准
- •Pregnant women
- •Women with any other vaginal or cervical pathology like cervical polyp, cervical erosion, carcinoma cervix, etc.
- •Women who have had previous treatment for Bacterial vaginosis
- •Menstruating at the time of examination.
结局指标
主要结局
RECURRENCE OF BACTERIAL VAGINOSIS BY ASSESSING NUGENT SCORE (IF ABOVE SEVEN) OR AMSELS CRITERIA POSITIVE
时间窗: After 30 days of giving treatment
次要结局
- 1. patients’ satisfaction by life style questionnaire(After 30 days of giving treatment)
- 2. Side effects(After 30 days of giving treatment)
研究者
Sakshi Chandak
Datta Meghe Institite of Higher Education And Research(du)
